Job Description
Core Responsibilities
- Execute commissioning and qualification deliverables for facilities and utilities.
- Author, review, and approve pre- and post-execution validation documents.
- Ensure adherence to GMP, GXP, and company validation standards.
- Maintain validated state of equipment, utilities, and facilities.
- Support CAPA (Corrective and Preventive Actions) investigations for validation failures.
- Participate in internal/external audits and regulatory inspections.
- Provide documentation and technical support to sustain compliance.
- Work with engineering teams on new installations to ensure commissioning documentation meets cGMP requirements.
- May supervise contract validation resources to ensure timely completion of tasks.
Qualifications
- Education: Bachelor’s degree in engineering, Chemistry, Biology, or related life sci...